An interventional study of Placement of a dental implant in Jaw, Edentulous, Partially and Acquired Absence of Single Tooth, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-25.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Treatment
The investigators are asking subjects to take part in a research study of soft tissue (gums) and bone (jawbone) healing around dental implants following tooth extraction. The investigators want to compare how the gums and the bone changes shape with healing in two different scenarios:
Previous studies have shown that both methods work and can give good results. In fact the two methods are used routinely as part of standard care but it is not known if the two procedures are equally good since they have never been compared in one same research study.
This controlled, randomized clinical trial (RCT) is designed to compare soft and hard tissue dimensional changes for two commonly used approaches for replacing a recently extracted tooth by means of a dental implant, i.e. immediate implant placement (Type 1) or early implant placement (Type 2). Additionally, this study will evaluate the association between the osseous anatomy and implant position with soft and hard tissue changes.
Extraction sites will include maxillary and mandibular anterior and premolar teeth having intact adjacent teeth. Implants placed for this study will be SLA surface, bone level design, Straumann BL RC (Bone Level Regular Cross-fit ) 4.1mm or BL NC (Bone Level Narrow Cross-fit ) 3.3mm diameter implants at 8, 10, 12 or 14mm in length.
Immediate implant placement (Type 1) resulting in a horizontal defect dimension (HDD) will receive bone grafting, using freeze dried bone allograft (FDBA)(Straumann Allograft GC®) and will be covered by a resorbable membrane (BioGide®).
For the implants randomized to type 2 implant placement, the extraction socket will be filled with a collagen plug and allowed to heal for 4 to 8 weeks before the implant will be placed. Simultaneous guided bone regeneration (GBR) will be performed using FDBA (Straumann Allograft GC®)and a resorbable collagen membrane (BioGide®). The type 2 implant placement procedure will follow the guidelines as described by Buser et al. (2008).
All implant placement will follow standard protocols utilizing tapping and placement according to the manufacturer's guidelines.
171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.
This study's enrollment of 38 is above the median of 33 across 146 interventional studies indexed under Jaw, Edentulous.
Browse Jaw, Edentulous studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placement of a dental implant: Implant is placed immediately following tooth extraction in one surgical procedure
Procedure: Placement of a dental implant
Placement of a dental implant: Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure.
Procedure: Placement of a dental implant
Type 1 implant placement Type 2 implant placement
Also known as: Straumann, SLActive, Dental Implants
Mid Facial Mucosal Level at Implant Site
Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.
Time frame: 3 months after crown delivery
PES/WES (Pink Esthetic Score, White Esthetic Score).
The PES and WES scales are 10 point scales, made up of 5 categories, each with a 2 point value. Each category is scored out of 2, and the scores totaled to give an optimal score out of 10. Any score of 6 or higher out of 10 would be considered a good clinical outcome. the PES categories focus on the gum area, and the WES categories focus on the tooth. The scores for PES and WES are totaled, to give a score out of 20, with 20 being the highest possible score (best outcome). The values are totaled and a mean score of all the readings is reported.
Time frame: 3, 6, 12, 24, 36, 48, 60 months after crown delivery
Probing Depth
The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported.
Time frame: 3, 6, 12, 24, 36, 48, 60 months after crown delivery
Modified Plaque Index
Measurement of amount of plaque build-up on teeth, using a scale of 0 (no plaque detection), to 3 (an abundance of soft matter). The scores are totaled and a mean score reported.
Time frame: 3, 6, 12, 24, 36, 48, 60 months after crown delivery
Modified Bleeding Index
Bleeding from the gums is measured on probing the gum and measured on scale of 0 to 5, with 0 being the best outcome, with no bleeding, and 5 being the worst outcome, with spontaneous bleeding. The scores are totaled and a mean score reported.
Time frame: 3, 6, 12, 24, 36, 48, 60 months after crown delivery
Radiographic Bone Level
Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.
Time frame: Up to 5 years after baseline
| Milestone | Type 1 Implant Placement | Type 2 Implant Placement |
|---|---|---|
| Started | 19 | 19 |
| Completed | 17 | 15 |
| Not completed | 2 | 4 |
Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.
| mm | Type 1 Implant Placement | Type 2 Implant Placement |
|---|---|---|
| Mid Facial Mucosal Level at Implant Site | 0.54 ± 0.18 | 0.47 ± 0.31 |
The PES and WES scales are 10 point scales, made up of 5 categories, each with a 2 point value. Each category is scored out of 2, and the scores totaled to give an optimal score out of 10. Any score of 6 or higher out of 10 would be considered a good clinical outcome. the PES categories focus on the gum area, and the WES categories focus on the tooth. The scores for PES and WES are totaled, to give a score out of 20, with 20 being the highest possible score (best outcome). The values are totaled and a mean score of all the readings is reported.
| units on a scale | Type 1 Implant Placement | Type 2 Implant Placement |
|---|---|---|
| PES/WES (Pink Esthetic Score, White Esthetic Score). | 13.67 ± 0.61 | 12.51 ± 0.65 |
The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported.
| mm | Type 1 Implant Placement | Type 2 Implant Placement |
|---|---|---|
| Probing Depth | 3.06 ± 0.18 | 2.93 ± 0.18 |
Measurement of amount of plaque build-up on teeth, using a scale of 0 (no plaque detection), to 3 (an abundance of soft matter). The scores are totaled and a mean score reported.
| units on a scale | Type 1 Implant Placement | Type 2 Implant Placement |
|---|---|---|
| Modified Plaque Index | 0.18 ± 0.10 | 0.27 ± 0.15 |
Bleeding from the gums is measured on probing the gum and measured on scale of 0 to 5, with 0 being the best outcome, with no bleeding, and 5 being the worst outcome, with spontaneous bleeding. The scores are totaled and a mean score reported.
| units on a scale | Type 1 Implant Placement | Type 2 Implant Placement |
|---|---|---|
| Modified Bleeding Index | 0.12 ± 0.08 | 0.07 ± 0.07 |
Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.
No measurements were reported for this outcome.
Collected over Up to 3 months after crown delivery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Type 1 Implant Placement | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Type 2 Implant Placement | 0/15 (0%) | 0/15 (0%) | 2/15 (13.3%) |
| Event | Type 1 Implant Placement | Type 2 Implant Placement |
|---|---|---|
| Swelling and bruisingSurgical and medical procedures | 0/17 | 2/15 |
| Age, Continuous(years) | Type 1 Implant Placement | Type 2 Implant Placement | Total |
|---|---|---|---|
| Mean | 52.5 ± 15.6 | 50.9 ± 14.6 | 51.8 ± 14.9 |
| Sex: Female, Male(Participants) | Type 1 Implant Placement | Type 2 Implant Placement | Total |
|---|---|---|---|
| Female | 8 | 6 | 14 |
| Male | 9 | 9 | 18 |
| Race and Ethnicity Not Collected(Participants) | Type 1 Implant Placement | Type 2 Implant Placement | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Type 1 Implant Placement | Type 2 Implant Placement | Total |
|---|---|---|---|
| United States | 17 | 15 | 32 |
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio